FDA approves durvalumab for advanced urothelial carcinoma

The FDA granted accelerated approval to durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

The agency also approved the VENTANA PD-L1 Assay (SP263, Ventana Medical Systems) as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.

The FDA based its approval of durvalumab (Imfinzi, AstraZeneca) in part on data from a single-arm trial that included 182 patients with locally advanced or metastatic urothelial carcinoma. All patients progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Study participants received 10mg/kg durvalumab via IV every 2 weeks.

Researchers reported a confirmed objective response rate by blinded independent central review of 17% (95% CI, 11.9-23.3). Median response duration had not been reached (range, 0.9+ months to 19.9+ months).

The VENTANA PD-L1 Assay showed ORR was 26.3% (95% CI, 17.8-36.4) among 95 patients with a high PD-L1 score, and 4.1% (95% CI, 0.9-11.5) among 73 patients with a low or negative PD-L1 score.

The most common adverse reactions included fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema and urinary tract infection. Forty-three percent of patients experienced grade 3 to grade 4 events. These events included pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency and diabetes.

The FDA previously granted durvalumab priority review and breakthrough therapy designation for this indication.

The agency recommended a durvalumab dose of 10 mg/kg administered as an IV infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.